Method and article of manufacture for performing clinical trial budget analysis

ABSTRACT

An electronic method is provided of analyzing budgets for clinical trials. A clinical trial budget is entered into a processor. The budget includes activities and associated activity costs. The activities are classified into a set of standardized service categories. The processor then electronically allocates the associated activity costs with the respective standardized service category so that budget costs can be objectively analyzed. The budget further includes assumption specifications. The processor further calculates per unit costs of the assumption specifications. The activities and the associated activity costs are then equalized against reference assumption specifications using at least the per unit costs via calculations performed in the processor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of copending U.S. application Ser.No. 12/121,822 filed May 16, 2008, which is incorporated by referenceherein.

This application claims the benefit of U.S. Provisional Application No.60/939,059 filed May 19, 2007 entitled “Clinical Trial Budget Analysis.”

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to the analysis of clinical trialbudgets. More particularly, this invention relates to acomputer-implemented method for analyzing budgets for clinical trials.

2. Background

The life sciences industry includes pharmaceutical and biotechnologycompanies that are required to perform various phases of clinical trials(also referred to as clinical studies) on new drugs, compounds andmedical devices before they can obtain marketing approval from the U.S.Food and Drug Administration or a foreign counterpart. Clinical trialsare expensive to conduct and require effective budgeting processes inorder to keep costs under control and obtain the best return oninvestment. The budgeting process for conducting a clinical trial iscomplex since is often requires the pharmaceutical or biotechnologycompany, known as the “sponsor” of the trial, to use many differentvendor suppliers in addition to its own resources. The process used toselect between potential vendor suppliers can profoundly affect asponsor's clinical trial budget since vendor suppliers can price thesame services in significantly different ways and amounts, and thebudgeting processes currently used by sponsors cannot identify thesepricing differences without significant time and expense as is describedbelow in greater detail.

FIG. 1 illustrates the following example of the flow of budgetinformation into a biotechnology company, which is not intended to belimiting in any way. Several different lists of activities andassociated costs (LOAACS) shown on FIG. 1 contain many itemizedactivities and costs that are proposed in order to complete a clinicaltrial under a set of specification assumptions. According to anembodiment of the invention, this set of specification assumptionsinclude number of sites, number of patients, number of countries, andthe like, that are estimated to be necessary to complete a specificclinical trial. A vendor supplier (a Contract Research Organization orCRO for this example) or an in-house team is given a set of assumptionspecifications with a list of requested activities by the biotechnologycompany in the form of a document called a “Request for Proposal” (RFP).The RFP sets forth the specification assumptions and the list ofrequested activities from which a responder must prepare a budgetcontaining the costs for the activities under the specificationassumptions. CROs respond to an RFP in their own standard format andsend a number of standard and non-standard documents to thebiotechnology company, which is then responsible for analysis of thebudget information to properly cost and then perform a clinical trial.

A “budget” as described herein, may be an internal project budget or abid for outsourced work.

Although the biotechnology company carefully designs the RFP and theCROs or in-house teams might carefully prepare the RFP responses, it isvery difficult and time consuming to analyze the budgets provided. Thishappens because of many different reasons: many activities are necessaryto conduct a trial including teleconferences, training, meeting time,and the like; there is no standard terminology; there are no standardcategorizations for these activities. For example, one person preparinga budget might use the term “teleconference” for a training sessionbecause that is the way the training is conducted, while another personreserves the term “teleconference” for weekly meetings conducted on thetelephone. To further add to the confusion, the categories for theseactivities are not standardized. For example, one person analyzing abudget might classify the “teleconference-training” activity under thecategory “initial study set up,” while another person will categorizethe same activity under the category of “monitoring” because thetraining is being done for the monitors who will monitor the trial. Asthere are hundreds of activities and multiple categories, confusion andmisunderstandings can quickly multiply.

Similar budget process problems can and do occur within a pharmaceuticalcompany or other companies in the life sciences industry. While thisexample shows the flow of information in the industry to obtain budgetproposals from vendor suppliers such as Contract Research Organizations(CROs), a similar process is used to formulate budgets for other typesof vendor suppliers and for in-house resources. Again, a similar processis used if a combination of in-house and vendor resources are used.

In order to try to reduce the confusion, some biotechnology andpharmaceutical companies write detailed RFPs, which provide standardcategories and standard terms for activities. Persons who preparebudgets are asked to provide detailed information for the budget withinthe RFP. A goal of this is to make the analysis process simpler, so thatthe budgets can be compared, contrasted, and costs understood easily ifthere is a change in any of the assumption specifications. However,completing and comparing budgets within an RFP has not solved theproblem. The reasons that confusion and errors still exist are due tomany factors including the following factors:

-   -   1. No benchmark libraries of standard terms, costs, categories,        activities are easily available.    -   2. There are few staff that have the detailed financial and        operational expertise to do a proper analysis.    -   3. There are little or no performance metrics linked to cost        metrics.    -   4. Teams and supplier vendors may unintentionally or        purposefully leave gaps in the lists of activities needed to        complete a clinical trial.    -   5. Supplier vendors are unable to conform their internal        costing, pricing and budgeting to the many different RFPs that        their clients expect them to complete.

Unfortunately, the result of the confusion surrounding the analysis ofbudgets is that the biotechnology companies and others managing thebudgets cannot, for example, make accurate pricing comparisons orcompile accurate budgets. These mistakes cause a biotechnology companyto pay more than is necessary for some activities. Another problem isthat budget overruns are high due to gaps in activities that have notbeen budgeted. In addition, with the lack of proper budget analysis, theclinical trial often suffers from poor performance, delays and failure.

SUMMARY OF THE INVENTION

The present invention overcomes the drawbacks of the prior art through acomputer-implemented method of analyzing budgets for clinical trials. Inone embodiment of the present invention, a person analyzing a budget fora clinical trial may accept the budget in any format, using any commonterminology in the industry and any common categorization. The presentinvention may accept this information, process it through a series ofsteps, and produce reports that make the analysis simple and accurate.There is no limitation to the reports that can be produced by thepresent invention, and several examples are provided below. In oneembodiment, the present invention organizes and analyzes the budgetsusing libraries of benchmark metrics for costs, terminology,categorization, and the like. Algorithms may take into account thecomplexity of the clinical trials, the therapeutic area (e.g.,cardiology, neurology, and the like). Furthermore, the information canbe analyzed according to phases of clinical development, adaptivetrials, and the like, that are done in any country around the globe.

The present invention also provides a biotechnology company with ananalysis, reports and recommendations for selecting a clinical researchorganization to conduct a clinical trial. Pharmaceutical andbiotechnology companies can also attain an “apples to apples comparison”of budget options and supplier options.

The present invention may be used to assists companies that performclinical trials in understanding what may be the most efficient andcost-effective way for running a given trial whether it be usinginternal resources, or outsourcing, or a combination of both.

In one preferred embodiment, the present invention inputs one or moreclinical trial budgets into a processor. The budget may includeactivities such as monitoring activities, data management activities,and biostatistical activities, and the like, that are conducted duringclinical trials. The budgets may also include prices and costsassociated with these activities. Costs can be analyzed in dollars,pounds, or any other currency.

In an embodiment of the present invention, reports are produced thatcompare and reference assumptions and their associated costs. Thesereferenced assumptions may be contained in libraries of benchmarkinginformation on cost metrics, service metrics, performance metrics, timeto perform activities, standard terminology for activities, staffingrates, and the like. The reports may include a series of financial andoperational analyses showing where the discrepancies are within anysubmitted vendor/supplier budgets or proposals, or within client'sinternal or resource plan.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofpreferred embodiments of the invention, will be better understood whenread in conjunction with the appended drawings. For the purpose ofillustrating the invention, there is shown in the drawings embodimentswhich are presently preferred. It should be understood, however, thatthe invention is not limited to the precise arrangements andinstrumentalities shown.

In the drawings:

FIG. 1 shows an example of the flow of budget information into abiotechnology company for a clinical trial.

FIG. 2 shows a sample of reports provided in accordance with preferredembodiments of the present invention.

FIG. 3 is a flow diagram of the entire process that is performed by onepreferred embodiment of the present invention.

FIG. 4 illustrates a standardization process according to one preferredembodiment of the present invention.

FIGS. 5A-5F, taken together, show the calculation of monitoring visitsbased on time (frequency of visits) according to a referencespecification assumption in accordance with one preferred embodiment ofthe present invention.

FIG. 6 illustrates a normalization process according to one preferredembodiment of the present invention.

FIG. 7 illustrates an equalization process according to one preferredembodiment of the present invention.

FIG. 8 is a flowchart of a process used to create a business analysisaccording to one preferred embodiment of the present invention.

FIGS. 9A-9P, taken together, is a request for proposal (RFP) provided bya biotechnology company.

FIGS. 10A-10B, taken together, show a response sent back to thebiotechnology company by a particular Clinical Research Organization(CRO) in response to the RFP.

FIG. 11A-FIG. 11U shows the RFP response that was given to thebiotechnology company by a CRO.

FIGS. 12A-12P, taken together, show a list of activities and associatedcosts that were given to the same biotechnology company by a differentCRO FIGS. 13A-13EEE, taken together, show three sets of CRO responses.

FIG. 14 shows an excerpt from a CRO proposal that highlights adiscrepancy in their proposal.

FIG. 15 shows a spreadsheet that relates to the discrepancy highlightedin FIG. 14.

FIGS. 16A-16B and 17-19 show spreadsheets related to RFP services.

FIGS. 20-21, 22A-22B and 23 show summary reports related to RFP's.

FIG. 24 is a hardware configuration diagram in accordance with onepreferred embodiment of the present invention.

FIGS. 25A1-25G2, taken together, list algorithms and formulas used tocalculate and produce reports.

FIG. 26 shows a summary report of a business analysis case studyperformed in accordance with a preferred embodiment of the presentinvention.

FIGS. 27-36 show a sample financial report associated with the businessanalysis case study.

DETAILED DESCRIPTION OF THE INVENTION

For purposes of explaining the present invention, specific embodimentswill be described. These embodiments are exemplary only, and are notintended to limit the scope of the invention.

FIG. 2 shows a sample of reports provided by the present invention anddemonstrates what the reports provide compared to the current process ofanalysis. Providing an easy way for companies to analyze budgets forconducting clinical trials has proven to play a large part in savingtime and money, has taken the risk out of the clinical trial process,and has reduced the length of time needed to conduct a clinical trial.

FIG. 3 is a flow diagram of the entire process that is performed by anembodiment of the invention. This process occurs by inputting clinicaltrial budget information into a processor, including assumptionspecifications, activities and associated costs. As seen in FIG. 3, thedata flow is as follows according to an embodiment of the invention:when the budget and information—LOAACs (Lists of Activities andAssociated Costs), RFP, RFP responses, and any accompanying materialthat is part of the process are received, shown in A, they are inputtedinto the processor, shown in B. The many different ways for imputingsuch information into a processor are well known to those skilled in theart, including through a user interface, downloading from the web,importing an electronic files, scanning, and the like. In an exampleselected to illustrate an embodiment of the invention, FIGS. 9A-9P,taken together, is an RFP provided by a biotechnology company. As can beseen from this example, these RFPs are very detailed and exacting as tohow the Biotechnology Company wants to see the responses returned. TheRFP contains information about the trial. FIG. 9A shows the informationabout the trial protocol, such as the indication and objectives. FIG. 9Bshows the timelines (dates). FIG. 9C-9F lists all of the assumptionspecifications. The RFP also provides a very specific structure for theactivities and the cost of the activities as seen in FIG. 9G-9P. In theillustrated example, there five proposals were sent in against the RFPand three were used in this example. Lists of Activities and AssociatedCosts (LOAACS) are often sent instead of, or in conjunction with, theRFP response. FIG. 10A-10B shows the LOAACs (consisting of just twosummary pages) that were sent back to the biotechnology company byClinical Research Organization number 2 (CRO2) in response to therequest for a proposal to conduct a specific clinical trial. FIG.11A-FIG. 11U shows the RFP response that was given to the biotechnologycompany by CRO2 that were sent with the LOAACs. FIG. 11E line 1.1 showshow CRO2 has filled in one of the boxes on the RFP with dollar amounts,units, and the like.

FIGS. 12A-12P, taken together, show the LOAACs that were given to thesame biotechnology company by a different Clinical Research Organization(CRO4) in response to the same request for a proposal to conduct thesame clinical trial. The LOAACs from CRO4 contain much detailedinformation, which one would think would help the biotechnology companymake a decision, however, it just makes the analysis and comparison moredifficult. To add to the confusion, CRO4 provided a lot more informationthan requested and added other types of information that were notrequested. For example, FIGS. 12A-12D show columns for the activitiesand assumption specifications for a ‘one month follow-up’, a ‘six monthfollow-up’, and a ‘one year follow-up’. This information is entirelydifferent than any of the CROs provided. FIGS. 12E-12P show theactivities and costs, but do not exactly match the assumptions on theprior figure. Extra information, although it might seem to be useful, isoften confusing and difficult to analyze and compare with otherinformation. FIGS. 13A-13EEE, taken together, show three sets of CRO4RFP responses, namely, FIGS. 13A-13S, FIGS. 13T-13LL, and FIGS.13MM-13EEE. These sets of figures show three different RFP responsesthat correspond to the proposed ‘one month follow-up’, ‘six monthfollow-up’, and ‘one year follow-up’ scenarios proposed by CRO4. Themost confusing aspect of these three responses is that, as can be seenon FIG. 13A, FIG. 13T and FIG. 13MM, the line for ‘follow up period’shows as 6 months. However on FIG. 13E, the costs for item 1. ProjectManagement is $140,499. This is the cost associated with the 6 monthsassumption specification shown on FIG. 13A. Yet in FIG. 13X, the costsfor item 1. Project Management is $144,399. This cost is for the 6months assumption specification shown on FIG. 13T. Yet again, FIG. 13QQshows that the costs for item 1. Project Management is $148,149. Thiscost is for the 6 months assumption specification shown on FIG. 13MM.Preferred embodiments of the present invention identify suchdiscrepancies.

The trial sponsor did not specifically request this information, butoften a CRO includes other options and budgets from those requested. Itis important to note that one of the important problems that the currentembodiment of the invention solves, is that a non-clinical member of thebiotechnology team has clinical data about the trial that is translatedinto understandable financial information to make a better decision. Theclinical member of the team also gets financial information translatedinto clinical information, so it is easy for them to understand. Thistype of invention solves the problem that it is rare and costly to findclinical resources with financial backgrounds and financial resourceswith clinical problems.

Only two CROs are discussed in this example used to illustrate one ofseveral possible embodiments of the invention. However, there is nolimit to the amount or size of information that the present inventioncan analyze.

Standardization Process

Standardization is the process of classifying the activities into a setof standardized service categories. FIG. 4 illustrates thestandardization process according to an embodiment of the invention,which can be done automatically, by the processor. This can be animportant process because all of the accompanying materials received maybe preferably reconciled and crosschecked, and discrepancies may bepreferably logged into the libraries of benchmark metrics. Thestandardization process may preferably identify discrepancies within thematerials (RFP response, LOAACs) sent to the biotechnology company. Thismay be done in an essentially “blinded” way so that bias is removed inthe process. The LOAAC's description of services are crosscheckedagainst the unit of activities, checked against the metric (assumptionspecification) in the RFP and the protocol and checked mathematicallyfor accuracy in calculations of units and costs. The services that arenamed in the LOAACs are checked against the benchmark libraries ofterminology. The next step identifies the activities that are nameddifferently on each LOAAC, yet are actually the same activity. Anelectronic translator automatically performs some or all of theclassification. The electronic translator includes a dictionary ofactivities and their associated standardized service categories so thatit can then categorize all the services named on the LOAACs intostandard categorizes, for comparison.

According to an embodiment of the invention, the process of inputtingthe clinical trial budget information into the processor may preferablyinclude the cataloging, inventorying, and assembly of all materials thathave been received, and then adding them to the libraries of benchmarkmetrics. The budget includes activities and associated costs.

An example of a discrepancy is illustrated in FIG. 14, which is anexcerpt of the information sent to a biotechnology company by CRO1.Besides the RFP response and the LOAACs, CRO1, has included additionalinformation in paragraph form, as seen in this FIG. 14. In paragraph C,the underlined sentence explains that CRO1 will provide the monitoringvisit activities every six weeks. This is discrepant with what CRO1 hasshown in their LOAACs related to monitoring visits on FIG. 15. On line5.2.1, CRO1 is budgeting for 453 visits. These two pieces of informationare contradictions, but not easy to spot, because they are in differentforms. This embodiment of the invention will identify and display thediscrepancies, as well as the correct number of monitoring visits neededfor a clinical trial that has a specification assumption of 36 monthsfor the trial timeline, and a specification assumption for frequency ofmonitoring visits at every six weeks. The correct number of monitoringvisits would be 3,900 visits. The gap in the activity of monitoringvisits is 3,447. This calculation is embedded in FIG. 5F in the lineitem called “Interim visits—paper CRFs” in row 36, with the formulashown in far right of column I.

FIGS. 5A-5F, taken together, show the calculation of monitoring visitsbased on time (frequency of visits) according to the referencespecification assumptions (e.g., RFP from sponsor).

This embodiment of the invention discovers these errors without needingtrained project staff and finance experts to dig deeply into threedifferent documents and cross-reference all calculations, costs,activities and assumption specifications. Some of these steps in theprocess may be done simultaneously or, depending on the situation,skipped entirely, according to an embodiment of the invention.

According to an embodiment of the invention, FIG. 4 includes the stepsthat the processor makes in order to classify the activities into a setof standardized service categories such as “data management,” “projectmanagement,” “safety,” and the processor allocating the associatedactivity costs with the respective standardized service category. Anelectronic translator can be used that references dictionaries of termswithin the processor to match activities to the nearest similar term.

According to an embodiment of the invention, details regarding the unitsand costs for the trial's specification assumptions, as shown in ascreen shot in FIGS. 16A and 16B, specification assumptions are inputtedduring the standardization process. FIG. 16A shows the first 40 linesand FIG. 16B shows the rest. The input may reflect the specificationassumptions from the request for proposal from the biotechnologycompany, in this example. This step is done to generate within anembodiment of the invention, the benchmark specification assumptions andcosts in standard categories of professional fees, as seen in FIG. 17for CRO2 and in FIG. 18 for CRO4. The processor calculates thestandardized activities together with their associated costs, based onthe specification assumptions from the LOAACs from CRO2 and CRO4. Thestandardized items and their dollar amounts per standardized categoryare then generated according to an embodiment of the invention as shownin FIG. 19. This standardization process may include services and coststhat are associated with the activities, sorted into the same standardcategories. This may all be done based on libraries of activitiesterminology, libraries of category terminology, and libraries of costand pricing methods that are used to compare and find common terms andcategories, and the like. There is no limit to the libraries, andprovisions can be made for continuous update of all libraries ofbenchmark metrics and algorithms used.

According to an embodiment of the invention, the standardization processmay preferably complete crosschecks. These crosschecks may preferablycompare each LOAAC against the RFP for a specific trial. Activities maybe identified that are the same in meaning but are named differently ineach LOAAC. At the end of this step, the new, standardized LOAACs maydisplay all of the activities and the corresponding units and costsmetrics itemized for CRO2 and CRO4. There is no limitation to the numberof CROs, the activities listed, the costs, and the like, that can beprocessed by this embodiment of the invention. A result of thisstandardization process is that all of the activities may be in the sameformat, using naming terminology that is now common to CRO2 and CRO4.All costs may be listed under commonly named categories, enablingaccurate comparison of specification assumptions and costs.

Normalization Process

According to an embodiment of the invention, the next step in FIG. 3 isthe normalization process that provides per unit costs, to compare theactivities and associated activity costs to reference assumptions. Theprocessor can calculate per unit costs of the assumptionsspecifications. The preferable components of this step are illustratedin FIG. 6. A clinical trial will have assumption specifications (e.g.,number of patients, number of sites, number of months to completeenrollment, total number of months for the trial, number of countries).One or more of the assumption specifications are input into theprocessor, which then calculates per unit costs of the assumptionspecifications.

According to an embodiment of the invention, this step crosschecks eachLOAAC assumption specification against reference assumptions—e.g., theRFP, another iteration of a budget. Discrepancies are then preferablyhighlighted and deltas reported (differences between the RFP and LOAACs,for example). In addition, the normalization process may crosscheck eachLOAAC unit with the unit costs, and identify discrepancies and reportthe deltas of the level of services. The normalization process may alsocrosscheck each LOAAC description of services against the units proposedto identify discrepancies and report the deltas in costs.

According to an embodiment of the invention, the normalization processthen performs the following: (1) check on the feasibility of the unitsof activities and the costs against benchmark metrics for trials ofsimilar size, scope, and therapeutic area; (2) reconcile all totals ofunits and financials—check the entire math, now that everything isstandardized, calculate; and (3) display the costs and numbers ofactivities into units such as “cost per patient,” “cost per site,” “costper page,” “cost per month,” and “cost per monitoring visit.” Thisdiscloses that if CRO2 adds sites, for example, it will cost ‘X’ persite. If the trial requires more monitoring visits, the amount this willcost with each CRO, based on the LOAACs, becomes known.

According to an embodiment of the invention, the normalization reportmay preferably classify costs and numbers of activities into bucketssuch as “cost per patient,” “cost per site,” “cost per page,” “cost permonth,” and “cost per monitoring visit.” This can be an importantguideline for watching for overruns and points for further discussion.This report may also point out differences in monitoring intervals.

According to an embodiment of the invention, the normalization processmay preferably compare the total cost for the sum of activities listedin the standardized LOAACs, standard categories, for CRO2 and CRO4. Acomparison may be made of the total cost budgeted for each standardcategory listed in the standardized LOAACs. The normalization processthen preferably calculates the per unit costs so that a biotechnologycompany will have immediate information on the changes in the budgetsthat will occur based on any change in the number of units. The unitsare changed often in clinical trials, and a biotechnology company isusually unable to understand the resultant budget change because so manyactivities and associated costs are affected by a change in the trial.

Equalization Process

According to an embodiment of the invention, the next step is theequalization process referenced in FIG. 3E, which equalizes theactivities and the associated activity costs against referenceassumption specifications (e.g., benchmark metrics, RFP, one of the CROLOAACs), using at least the per unit costs. The preferable components ofthis step are illustrated in FIG. 7. The equalization process maypreferably equalize the activities and the associated activity costs(LOAACs specification assumptions and costs) against referenceassumption specifications, using at least the per unit costs. Thesereference specifications can be the RFP or benchmark specificationassumptions for a trial of the same scope and therapeutic area. Thisstep allows an accurate comparison between CRO2 and CRO4. An embodimentof the invention also provides more accurate information about the totalbudget because gaps in services have been identified and added to thetotal, as appropriate. An embodiment of the invention also has theability to provide budget information under different budget scenarios.For example, both CRO2 and CRO4 can be equalized to any specificationassumptions. A value of this capability is that reports may be providedthat are preferably adjusted for other specification assumptions withouthaving to request new cost information from CRO2 and CRO4, which cansave weeks on the process.

According to an embodiment of the invention, the equalization processmay preferably compare the total units and cost of each activity andcategory for CRO2 and CRO4 against each other. The equalization processmay also compare CRO2 against benchmark metrics, as well as CRO4 againstbenchmark metrics. Assessment is made in an embodiment of the inventionto check that activity is within the range of industry norms. Theequalization process may then identify additionally required activitiesthat may be missing in the CRO2 and CRO4 LOAACs. The cost for theseadditionally required activities plus the corresponding totals can thenbe calculated and displayed in the reports. This protects biotechnologyand other companies from budget overruns later in a trial, when thesurprising extra cost can adversely affect the stability of the company.

Summarizing this step of the process according to an embodiment of theinvention, the activities and the associated activity costs arepreferably “equalized” against reference assumptions such as benchmarkmetrics, using the per unit costs. These per unit costs may then be usedby an embodiment of the invention to automatically compare theactivities and the associated costs with the reference specifications.

In addition, according to an embodiment of the invention, normalizationand equalization can be used without standardization. For example, theclinical trial budget, including assumption specifications andassociated activity costs, could be analyzed by input into the processeither by data entry or in an electronic format. Per unit costs of theassumption specifications are calculated by the processor, and theactivities and associated costs are compared against referenceassumption specifications using the per unit costs. This equalization isdone if there are missing activities, or activities that areunder-budgeted. The equalization evens out the budgets for comparison,such as when one budget has different factors from another budget. Thismay include, for example, differences in length of trial.

Reporting Process

According to an embodiment of the invention, reports that may provideinformation about the analysis of the budgets and comparisons of budgetsare generated automatically. With the completion of each step of theprocess, reports may be generated based on algorithms that canpreferably compare and contrast the specification assumptions and costs.Algorithms may be preferably combined with information from LOAACs toproduce reports that present information that may not otherwise beattainable without significant time and expense.

Many algorithms and mathematical formulas are used during the process.Examples of these algorithms are shown in the accompanying application.There are libraries of algorithms and all formulas are enhanced as newinformation is added related to industry pricing, costing, and othermetrics. There is no limit to the number of algorithms that theprocessor uses to perform the functions.

According to an embodiment of the invention, it is not necessary for abiotechnology company to have received budgets, responses to RFPs, andLOAACs in order to perform an analysis of the budget needs for aclinical trial. FIG. 8 illustrates the direction the process takes ifLOAACs are available, or when the biotechnology company wishes to use anembodiment of the invention to determine which suppliers and budgets orspecifications might be appropriate for its protocol. FIG. 8 illustratesthe process when the biotechnology company has available LOAACS and whenit does not.

FIGS. 20, 21, 22 and 23 show examples of reports that may be produced bypreferred embodiments of the present invention.

FIG. 20 is a summary of supplier differences report and analysis. Thereport of findings is blinded on the List Of Activities and AssociatedCosts to remove bias (no CRO name is included). This information issummarized for the first time. All have advantages and disadvantages,but the key is to understand these advantages and disadvantages. Scopedifferences, missing items, and errors in the budgets are the reason forthe major discrepancy between the suppliers.

FIG. 20 report A shows a side-by-side comparison of CRO2 and CRO4assumption specifications compared to the RFP. This report is extremelyhelpful to a biotech company because it highlights the assumptions thatare not detailed and highlights the differences. In report A of FIG. 20,Key Variances are important deltas of differences between the RFP andLOAACs. “Not detailed” means that there is a dollar amount and somediscussion of the work, but no exact specifications. This reportprovides information that highlights that there were no exact number ofedit checks to be done, iterations of them, changes, or unit pricesfound by the processor in CRO2's LOAAC. There was just a dollar amountfor the main activity of data management. There is no dollar amountassociated with the activity, nor is there any discussion or activitiesmentioned in the LOAACs. ‘Yes’—means activity is included, as per thecosts, yet there is no number of units/specifications for the item.

Classifying costs into equivalent categories in order to enablecomparability forms standardized professional fees shown in Report B ofFIG. 20. The subtotal shows a huge difference in cost. The report alsohighlights that the costs are not inclusive. The questions that thisreport answers are helpful to a biotechnology company in understandingif they are getting a really good value at that low price, a really badjob, or if there is simply a misunderstanding or error about theassumptions specifications.

Report C in FIG. 20 shows adjustments to equalize specifications. Thealgorithms have calculations that add what is missing, and includenecessary work as requested by the RFP. This section adds the activitiesto correct the budgets, and add the cost of activities that CROs do notinclude, because the work is very difficult to perform cost effectively.These activities include integrating all the information into a single,analyzable database, and the reconciliations of the data once everythingis together. Reports D and E in FIG. 20 are different alternative setsof specification assumptions to run this clinical trial. These reportsillustrate how the invention can quickly display the cost that would becharged by either of the CROs, if the assumption specifications wereadjusted.

FIG. 21 shows the detail of differences in metrics (specificationassumptions for CRO 2 and CRO 4 and as stated in the RFP. The firsttable in this report standardizes specifications into major categoriesas seen in column one: Overall Assumptions, Project ManagementAssumptions, Monitoring Assumptions, Data Management Assumptions,Biostats Assumptions, and Safety. These are the categories of activitiesthat are necessary to complete the trial. This standardization andcategorization sorts all supplier items into common terms so that youcan compare the specifications more accurately.

The number of items, and a note where items are ‘not detailed’ are shownin the column for any supplier. These columns let you quickly see whatis not included, or not detailed within the LOAACs. These items that arenot mentioned by the supplier may be important to the trial and will bediscussed more fully with them. Other items are not included in thebudget, but will be needed for the trial, are listed as well. The lastcolumn in this table shows the RFP specifications.

FIG. 22A provides a report on the financial comparison, showing thedollar amounts for CRO2 and CRO4. FIG. 22B shows other expenses andtheir totals lined up side-by-side in the standardized categories. Withthese reports, a biotech can see how the dollars compare for thestandard categories. Once the differences are identified, furtheranalysis of the activities, the cost of the activities, and theassumption specifications is performed and the results are displayed ina report that details normalized costs. The normalized costs identifiesthat the difference in cost is because there is a very specificdifference in a specific assumption specifications. FIG. 23 shows areport that details the normalized comparator information, takendirectly from the LOAACs. This report classifies costs and numbers ofactivities into buckets such as ‘fees (costs) per patient’, ‘cost persite’, ‘cost per page’, ‘cost per month’, and ‘cost per monitoringvisit’. This is an important guideline for watching for overruns, andpoints for further discussion. This report also points out differencesin monitoring intervals and the like.

It is not clear in supplier proposals that one supplier is actuallyproviding a lower cost project than the other. For example, looking atthe fee per site, fee per patient, and fee per month (normalized) onesupplier may appear higher or lower, but this may not actually be true.Monitoring visit metrics might not detail the hours per visit; thereforea complete comparison cannot be made.

FIG. 24 is a hardware configuration diagram for the current embodimentof the invention.

FIGS. 25A1-25G2, taken together, list the algorithms and the formulasused by the processor to calculate and produce all of the information inthe reports and the formatted reports as well. These formulas andalgorithms allow the processor to accept input and calculate and displaystandardized comparisons of the CRO LOAACs or RFP responses with thereference specifications (e.g., benchmark metrics and benchmarkingmetrics). Reference activities and costs are also calculated anddisplayed for analysis and comparisons for costs and assumptionspecification references. The preferred embodiment of the presentinvention also provides the assumptions specifications and the costs,both normalized and equalized. FIG. 25A is illustrated in two parts,FIGS. 25A1 and 25A2, indicating that this figure is larger than thepage.

According to an embodiment of the invention, the content of a completegenerated report may comprises one or more of the following:

Clinical Operations Information

-   -   1. Risk management analysis    -   2. Responsibilities clearly delineated

Data Consolidation

-   -   1. Integration control charts    -   2. Reporting controls    -   3. Performance metric tracking    -   4. Replacement of faulty suppliers

Financial Risk Analysis & Controls

-   -   1. Analysis Summary of Supplier Cost Differences    -   2. Normalized Costs Comparator Information—Apples-to-Apples    -   3. Details of Best-of-Breed suppliers and activities    -   4. Recommendations to avoid delays and budget overruns    -   5. Forms the basis of time and cost guarantees

Case Study

As seen in FIG. 26, the analysis and reports have a tremendous impact onthe project budget. This figure shows three actual examples from recentactual clinical trials completed. The magnitude of the cost avoided issignificant and this process has been able to consistently demonstratewhere there are substantial cost savings (averaging over 30%)attainable.

FIG. 27 shows an example of the cover page of output in accordance withone preferred embodiment of the present invention.

FIG. 28 is an excerpt of the output that illustrates money saved byperforming this process. This process saves time and eliminates wasteand inefficiencies. The biotechnology company is assured that they getspeed and protection, with no additional costs.

FIG. 29 shows an output that includes an analysis of risk based on theobjectives of a particular trial using benchmark metrics.

The analysis includes a risk matrix calculation that provides thecomfort and security that levels of exposure have been identified andanalyzed. This analysis is specific to the points of risk of the trialand is seen in FIG. 30.

FIG. 31 gives the biotechnology company a calculation of several optionsand their effect on risk mitigation in enrollment, drug supplyinventory, and the like.

FIG. 32 shows the comparison, of four alternatives in standardizedcategories as seen on the left. For example: Overall Assumptions,Project Management, Monitoring. Columns to the right quantifies unitsfor each category. This reveals what is not included or not detailed.This standardization is not easy to make. The current embodiment of theinvention provides this information. Importantly, reducing the scope, orreducing protections does not accomplish cost savings.

FIG. 33 shows dollars reclassified into standardized categories. Thisreport revealed that although the total project budget appears similar,there are huge discrepancies within the categories. For example,monitoring activities vary from $454,000 to $1.2 million. There is analmost $1 million difference between the highest and lowest costs.Different suppliers treat passthrough costs (another category ofactivity costs) very differently, which can result in budget overruns.

FIG. 34 is an example of commentary and recommendations that accompanythe other financial and risk reports.

FIG. 35 shows a report with per unit costs that compares vendors basedon normalized costs. The gross monitoring cost per visit varies greatlybetween CRO1 and CRO2 EDC (electronic data capture). There aresignificant differences between the supplier who bid with less sitesand/or a high unit cost. This lets the biotechnology company know howunit costs vary and who offers the best value.

FIG. 36 is a report of responsibilities and costs. It shows preciselywho is doing what activities and itemizes each component and theresponsible party. This shows the total budget with total transparency.These reports tie in to the reconciliations of costs during the conductof the trial.

The present invention may be implemented with any combination ofhardware and software. If implemented as a computer-implementedapparatus, the present invention is implemented using means forperforming all of the steps and functions described above.

The present invention can be included in an article of manufacture(e.g., one or more computer program products) having, for instance,computer useable media. The media is encoded with, for instance,computer readable program code means for providing and facilitating themechanisms of the present invention. The article of manufacture can beincluded as part of a computer system or sold separately.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described above without departing from the broadinventive concept thereof. It is understood, therefore, that thisinvention is not limited to the particular embodiments disclosed, but itis intended to cover modifications within the spirit and scope of thepresent invention.

1. An electronic method of analyzing budgets for clinical trials, themethod comprising: (a) inputting a clinical trial budget into aprocessor, the budget including activities and associated activitycosts; (b) classifying the activities of the inputted clinical trialbudget into a set of standardized service categories; and (c) theprocessor electronically allocating the associated activity costs withthe respective standardized service category so that budget costs can beobjectively analyzed.
 2. The method of claim 1 wherein the clinicaltrial further includes a set of assumption specifications, the methodfurther comprising: (d) inputting the set of assumption specificationsinto the processor; and (e) calculating in the processor the per unitcosts of the assumption specifications.
 3. The method of claim 2 furthercomprising: (f) equalizing the activities and the associated activitycosts against reference assumption specifications using at least the perunit costs via calculations performed in the processor.
 4. The method ofclaim 2 further comprising: (f) using the per unit costs to compare theactivities and the associated activity costs to reference assumptionspecifications via calculations performed in the processor.
 5. Themethod of claim 1 wherein step (b) is performed automatically by theprocessor.
 6. The method of claim 5 wherein step (b) further comprisesusing an electronic translator to automatically perform at least some ofthe classification, wherein the electronic translator includes adictionary of activities and their associated standardized servicecategories.
 7. An electronic method of analyzing budgets for clinicaltrials, the method comprising: (a) inputting a clinical trial budgetinto a processor, the budget including assumption specifications,activities and associated activity costs; (b) calculating in theprocessor per unit costs of the assumption specifications; and (c)equalizing the activities and the associated activity costs againstreference assumption specifications using at least the per unit costsvia calculations performed in the processor so that budget costs can beobjectively analyzed.
 8. An article of manufacture for analyzing budgetsfor clinical trials, the article of manufacture comprising acomputer-readable medium encoded with computer-executable instructionsfor performing the steps of: (a) inputting a clinical trial budget intoa processor, the budget including activities and associated activitycosts; (b) classifying the activities of the inputted clinical trialbudget into a set of standardized service categories; and (c) theprocessor electronically allocating the associated activity costs withthe respective standardized service category so that budget costs can beobjectively analyzed.
 9. The article of manufacture of claim 8 whereinthe clinical trial further includes a set of assumption specifications,and the computer-readable medium is encoded with computer-executableinstructions for performing the further steps of: (d) inputting the setof assumption specifications into the processor; and (e) calculating inthe processor the per unit costs of the assumption specifications. 10.The article of manufacture of claim 9 wherein the computer-readablemedium is encoded with computer-executable instructions for performingthe further step of: (f) equalizing the activities and the associatedactivity costs against reference assumption specifications using atleast the per unit costs via calculations performed in the processor.11. The article of manufacture of claim 9 wherein the computer-readablemedium is encoded with computer-executable instructions for performingthe further step of: (f) using the per unit costs to compare theactivities and the associated activity costs to reference assumptionspecifications via calculations performed in the processor.
 12. Thearticle of manufacture of claim 8 wherein step (b) is performedautomatically by the processor.
 13. The article of manufacture of claim12 wherein step (b) further comprises using an electronic translator toautomatically perform at least some of the classification, wherein theelectronic translator includes a dictionary of activities and theirassociated standardized service categories.
 14. The method of claim 1wherein steps (a)-(c) are performed for a plurality of budgets for thesame clinical trial, the method further comprising: (d) the processorgenerating a comparison report showing at least some of the standardizedservice categories and the associated activity costs for each of theplurality of budgets.
 15. The method of claim 7 wherein steps (a)-(c)are performed for a plurality of budgets for the same clinical trial,the method further comprising: (d) the processor generating a comparisonreport showing at least some of the activities and the associatedactivity costs for each of the plurality of budgets.
 16. The article ofmanufacture of claim 8 wherein steps (a)-(c) are performed for aplurality of budgets for the same clinical trial, and thecomputer-readable medium is encoded with computer-executableinstructions for performing the further step of: (d) the processorgenerating a comparison report showing at least some of the standardizedservice categories and the associated activity costs for each of theplurality of budgets.